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Is FDA Saying "No" More?

This article was originally published in RPM Report

Executive Summary

The Food and Drug Administration is keeping a close eye on what appears to be a sudden drop off in the approval rate for new molecular entities under standard review at the agency.

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The Approval Drought Continues

No matter how you look at the numbers, it was another bad year for new product launches in the US. FDA approved more new drugs than last year, but just barely. And the number of products going off-patent actually exceeded the number of new launches. The sparse crop of new drugs this decade means lean years ahead for the pharma industry.

The Approval Drought Continues

No matter how you look at the numbers, it was another bad year for new product launches in the US. FDA approved more new drugs than last year, but just barely. And the number of products going off-patent actually exceeded the number of new launches. The sparse crop of new drugs this decade means lean years ahead for the pharma industry.

Where Have All the New Drugs Gone

The drug approval drought keeps getting worse. FDA says it approved 20 new products during the year, one of the lowest totals in two decades. In fact, focusing on genuinely innovative medicines, the total was even worse. The good news is that 2006 should be a much better year. But focusing on 2006 misses the point: it's the long-term trend that matters. The hope for a turnaround relies on some leaps of faith. Industry is gambling that advances in drug development science will pay off-even though the first efforts to reap the fruits of the genomics revolution are one reason for the current drought.

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